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Hospital drip blamed for deaths still in use

Tim Barlass

An anaesthetic drip that has been blamed for about 20,000 deaths worldwide is still being used in Sydney and Melbourne.

Other countries banned the use of the drip in June and leading intensive care specialists have condemned its continued use in Australia.

It is being used in some hospitals in Sydney.

Experts at the Royal Prince Alfred Hospital, Royal North Shore Hospital and Melbourne's Austin Hospital say the starch-based drip increases risk of kidney disease and death.

Australia led scientific research into the risks of hydroxyethyl starch (HES), marketed locally as Voluven, but has been slow to withdraw it, unlike the US, Europe, Britain, Canada and Italy, the experts say.

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In June, the US Food and Drug Administration issued a high-status warning that said recent data indicated an increased risk of mortality and renal injury and concluded HES solutions should not be used in critically ill adult patients. Britain's regulatory authority issued an urgent recall of the product in June.

The drip is distributed by Fresenius Kabi Australia in Pymble, which is part of a global concern.

A Scandinavian study comparing HES with alternative saline drips found that for every 13 patients treated in the trial, one patient died as a result of receiving HES fluids.

Rinaldo Bellomo, the director of intensive care research at Austin Hospital, has criticised the government's Therapeutic Goods Administration for issuing ''a variety of platitudes''.

Professor Bellomo said: ''The TGA factually is the last major agency in the developed world to respond to the findings of the trials … I am disappointed [the ban] hasn't happened here.''

A BBC documentary interviewed Ian Roberts, of the London School of Hygiene and Tropical Medicine, who said: ''A treatment like this will have been administered to many millions of patients around the world. Say there was just a 2 per cent [rise] in the risk of dying - if a million patients get treated, 2 per cent of a million patients is 20,000. So these treatments could have caused … slaughter in our health services and we wouldn't have known.''

The documentary said scientific papers supporting the use of HES had been produced by a German doctor, Joachim Boldt, who was found to have used false data.

Professor Bellomo declined to extrapolate the number of Australian HES-related deaths but said ''thousands'' of units would have been used.

The belief is notification since the research means HES is unlikely to be used in intensive care but experts say it is in use during planned surgical procedures in some hospitals.

Simon Finfer, director of clinical intensive care research at Royal North Shore Hospital and a professor at Sydney Medical School and the George Institute for Global Health, was involved in last year's study that helped prompt the British ban. He believed HES should be withdrawn.

He said: ''I certainly know it is being used in some hospitals in Sydney'' and other states.

The head office of Fresenius Kabi, in Germany, said the European recommendation was based on a review of a handful of studies that had limitations and did not not justify withholding HES products from all critically ill patients.

It had appealed a recommendation to suspend the marketing authorisation for HES solutions in Europe with the aim of obtaining a re-examination of the study data.

The Therapeutic Goods Administration said it was yet to finish its full safety review but had already ordered a change to the product information and had advised practitioners of the changes.